Health Condition 1: C929- Myeloid leukemia, unspecified
Conditions
Interventions
Intervention1: Azacitidine 300 mg Film coated tablets: Dose Formulation: Tablet
Dose Strength(s):300 mg
Dosage Level(s) : 1 tablet of 300
Route of Administration: Oral
Duration of Dose: Each partici
Sponsors
Hikma Pharmaceuticals
Veeda ClinicalResearch Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with documented diagnosis of AML according to the 2022 updates of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukaemia. 2. Patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. The definitions of response criteria for CR or CRi are primarily those defined by the 2022 report from the European Leukemia Net (ELN) on AML as below: CR defined as bone marrow blasts less than 5%; absence of circulating blasts; absence of extramedullary disease; ANC equal to or more than 1.0 10^9/L (1,000/ L); platelet count equal to or more than 100 10^9/L (100 000/ L). CRi defined as all CR criteria, except for residual, neutropenia less than 1.0 10^9/L (1,000/ L) or thrombocytopenia less than 100 10^9/L (100 000/ L). 3. Patients who don t have a known or suspected hypersensitivity to Azacitidine or any other ingredient used in the manufacturing of Azacitidine. 4. Patients who are physically able for appropriate pharmacokinetics sampling according to principal investigator evaluation. 5. Patients who have a haematological profile appropriate for receiving Azacitidine 300 mg dose for 4 consecutive days as per the principal investigator assessment. 6. Patients who understand and voluntarily sign a written informed consent document prior to any study related assessments/procedures are conducted. 7. Patient is capable of consent. 8. Females of childbearing potential may participate, providing the subject meets the following conditions: Negative serum pregnancy test at screening, and willing to use effective contraception during and up to 6 months after study. 9. Male patients must be willing to use effective contraception during and up to 3 months after the study.
Exclusion criteria
Exclusion criteria: 1. Patients with history of drug or alcohol abuse 2. Female patients who are pregnant or lactating. 3. Patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study. 4. Patients with positive blood screen for HIV, Hepatitis B (HbsAG) or Hepatitis C (HCV) virus. 5. Patients with experience in any investigational drug in a clinical study within 6 months prior to study Day 1. 6. Patients has a difficulty fasting, consuming standard meals or history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption. 7. Patients does not agree to not be engaged in strenuous exercise at least one day prior to study drug administration until donating the last sample of the study. 8. Patients does not agree to not consuming any beverages or food containing grapefruit for at least two weeks prior to first study drug administration until donating the last sample of the study. 9. Patients does not agree to not consuming any beverages or food containing methyl-xanthines e.g., caffeine (coffee, tea, cola, energy drinks, chocolate etc.) and alcohol containing beverages at least 48 hours prior to first study drug administration until donating the last sample of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the bioequivalence of the Test Product (Azacitidine 300 mg Film coated tablets (300 mg Azacitidine) manufactured for Hikma Pharmaceuticals (MAH)) relative to Reference Product (Onureg 300 mg Film Coated Tablets (300 mg Azacitidine) manufactured by Celgene Corporation after a single oral dose administration in adult patients with AML under fasting conditions.Timepoint: On each period 14 blood samples will be collected, 1 predose sample at 0.00 hr and 13 post dose sample at 0.167 (10 mins), 0.333 (20 mins), 0.50 (30 mins), 0.75 (45 mins) ,1.00, 1.25, 1.50, 1.75, 2.00 ,2.50, 3.00, 4.00 and 5.00 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerabilityTimepoint: 1. Adverse Events (AEs) [Time Frame: Up to Day 4 at discharge]. 2. Change in clinical safety labs [Time Frame: Up to Day 4 at discharge]. 3. Follow-up by the PI or designee will be conducted by phone call within 7 to 14 days after the last drug administration. | — |
Countries
India, Jordan, Lebanon, Saudi Arabia, United Arab Emirates
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical research Limited
Outcome results
None listed